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Pharmacodynamic Analysis of Intravenous Remimazolam Tosylate for Sedation in Obese Patients: A Prospective, Double-Blind, Single-Center, Randomized Clinical Trial

Pharmacodynamic Analysis of Intravenous Remimazolam Tosylate for Sedation in Obese Patients: A Prospective, Double-Blind, Single-Center, Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117329
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-22
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

non-obese group,:Patients within each group were randomly assigned to receive one of five doses of remimazolam tosylate — 0.07, 0.12, 0.17, 0.22, or 0.27 mg·kg-1 — for anesthesia induction.
obese group:Patients within each group were randomly assigned to receive one of five doses of remimazolam tosylate — 0.07, 0.12, 0.17, 0.22, or 0.27 mg·kg-1 — for anesthesia induction.

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 ASA physical status I–III; 2 Age 18–60 years; 3 Patients scheduled for elective surgery;

Exclusion criteria

Exclusion criteria: 1 Patients undergoing liver resection or liver transplantation with a history of liver disease (history of liver disease, total bilirubin > 3.0 mg/dL, or aspartate aminotransferase/alanine aminotransferase > 2.5 times the upper limit of normal); 2 Renal disease (serum creatinine > 2 mg/dL); 3 Poorly controlled hypertension (e.g., systolic blood pressure > 160 mmHg despite antihypertensive therapy); 4 Diabetes mellitus (glycated hemoglobin > 9%); 5 Intolerance or allergy to benzodiazepines/GABA-A receptor agonists; 6 History of substance abuse; 7 Glaucoma; 8 Heart failure; 9 Peripheral arterial disease; 10 Chronic obstructive pulmonary disease (COPD); 11 Patients scheduled for regional anesthesia prior to induction; 12 Pregnant women

Design outcomes

Primary

MeasureTime frame
ED95 of LoC ;Mean arterial pressure;

Secondary

MeasureTime frame
The incidence of respiratory depression;the time to onset of RD;Narcotrend index;Heart rate ;

Countries

China

Contacts

Public ContactXia Feng

The First Affiliated Hospital, Sun Yat-sen University

fengxia@mail.sysu.edu.cn+86 136 8887 7856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026